가혹조건에서 면역글로불린제제의 중합물 생성 및 항보체 활성 평가

Polymers Production and Anti-complementary Activity Evaluation of Immunoglobulins under Stress Storage Conditions

Immunoglobulins for intravenous administration, classified as plasma-derived medicinal products, have the potential to form polymers due to protein aggregation. These polymers can activate the complement system, leading to adverse reactions, including fever and tachycardia. This study aims to investigate the correlation between the high content of polymers generated under stress conditions and complement consumption. At a stressed temperature of 60oC, all samples showed an increase in both polymers formation and complement consumption proportional to the storage period. Similar results were observed in a study where the pH was additionally adjusted to 7.0, with a notable increase in the activity of polymers indicating anti-complement properties. It is concluded that minimizing temperature and pH variations, which can impact not only the manufacturing process but also the results of quality control tests, is essential for ensuring the targeted product safety and efficacy.